Continuous infusion fluorouracil in the management of advanced breast cancer: A phase II study

Aims and background: The evaluation of unconventional schedules of well-kno wn drugs represents a promising avenue in the search for new regimens with a better therapeutic index in metastatic breast cancer. In particular, prot racted continuous infusion (PCI) of B-fluorouracil (5-FU) has yielded inter esting results in gastrointestinal malignancies and in breast cancer. Methods: From March 1996 30 consecutive patients with heavily pretreated br east cancer were treated with PCI 5-FU at a daily dose of 250 mg/m(2) by me ans of disposable elastomeric pumps until progression or toxicity. The medi an age was 54 years (range, 28-71) and median performance status was 1 (ran ge, 0-3), All patients but four were pretreated with anthracycline-containi ng regimens or taxanes; the median number of chemotherapy lines was 3 (rang e, 2-4), Metastatic sites were predominantly visceral in 60% of the patient population. Results: All 30 patients were evaluable for response and toxicity. The medi an duration of PCI was 20 weeks (range, 2-36 weeks). Two complete responses (7%) and eight partial remissions (26%) were observed, giving an overall r esponse rate of 33%, The median duration of response was six months (range, 4-9 months). Stabilization was observed in seven patients (23%) with a med ian duration of seven months (range, 3-9 months). The main toxic effects we re grade I-II mucositis and hematologic toxicity, while grade 3 hand-foot s yndrome was observed in eight patients (27%). Conclusions: This study confirms the efficacy and safety of 5-FU at this do sage and schedule in heavily pretreated women with advanced breast cancer. In order to improve on these results further studies are needed In a less a dvanced stage of the disease and together with other active drugs.